Paralysis, Paraplegia, Spinal Cord Injury, Tetraplegia
Conditions
Keywords
paraplegia, tetraplegia, Spinal cord injured, FES
Brief summary
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.
Detailed description
In a single surgical procedure electrodes will be inserted into muscles of the trunk and hip musculature. The electrode leads are connected to a stimulator/telemeter located in the abdomen. After a typical post-operative period of two to five days, neuroprosthesis recipients will be discharged to home for two to six weeks of restricted activity to promote healing of all surgical incisions. After a period of exercise and training, functional use of the neuroprosthesis will begin. Laboratory assessments of strength, balance, and functional abilities with and without the system, as well as the technical performance of the implanted components will be evaluated.
Interventions
DEVICEIRS-8 (8-Channel implanted stimulator-telemeter)
Surgical implantation of the 8-channel neuroprosthesis
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* C4-T12 * ASIA Scale A through C * Time post injury greater than 6 months * Innervated and excitable trunk and pelvis musculature * Absence of acute or chronic psychological problems or chemical dependency * Range of motion within normal limits * Controlled spasticity and absence of hip flexion and adduction spasm * Height and weight within normal limits * No history of balance problems or spontaneous falls * No history of spontaneous fracture or evidence low bone density * No acute orthopaedic problems * No acute medical complications * Adequate social support and stability * Able to speak and read English
Exclusion criteria
* Pregnancy * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility. | up to 36 months | Experiments involving the effects of trunk stimulation on postural alignment; trunk stability and posture on respiration, postural variation on seated interface pressures; effects of trunk stimulation on reaching ability; effects of trunk stimulation on seated stability, and personal mobility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Design a simple position controller | Up to 36 months | The position controller will be developed to keep the trunk posture at a neutral seated position while allowing movement to lean forward, backward, or side-to-side. Testing will be carried out with an automated pull system applied to the trunk which pulls the body in various ways (side-to-side, forward, backward) |
Countries
United States
Contacts
Primary ContactLisa M Lombardo, MPT
Backup ContactEmily C Johnson, BA
Outcome results
None listed